SHL Medical AG - Switzerland v Sanofi-Aventis Deutschland GmbH
[2023] APO 12
•17 February 2023
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
SHL Medical AG – Switzerland v Sanofi-Aventis Deutschland GmbH [2023] APO 12
Patent Application: 2016269707
Title:Syringe support and autoinjector
Patent Applicant: Sanofi-Aventis Deutschland GmbH
Opponent:SHL Medical AG – Switzerland
Delegate:Pradnya Satarkar
Decision Date: 17 February 2023
Hearing Date: Written submissions filed on 1 July 2022
Catchwords: PATENTS - extension of time to file evidence in answer - regulation 5.9 - whether applicant has made all reasonable efforts to meet filing requirements - whether applicant has acted promptly and diligently - whether circumstances beyond control - extension allowed
Representation: Patent attorney for the applicant: Griffith Hack
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2016269707
Title:Syringe support and autoinjector
Patent Applicant: Sanofi-Aventis Deutschland GmbH
Date of Decision: 17 February 2023
DECISION
The applicant has met the requirements of paragraph 5.9(2)(a) of the Patent Regulations. I grant an extension of the time for filing evidence in answer until 22 January 2022.
For the purposes of subregulation 5.8(2), this decision represents notice that all of the evidence in answer has been filed. The time for filing evidence in reply is 2 months from the date of this decision.
REASONS FOR DECISION
Background
This matter relates to a request for an extension of time to file Evidence in Answer (EIA) in the opposition to 2016269707 (the application) under Section 59 of the Act. The application in the name of Sanofi-Aventis Deutschland GmbH (the Applicant) was examined and advertised as accepted on 10 December 2020. On 17 March 2021, SHL Medical AG – Switzerland (the Opponent) filed a Notice of Opposition after gaining an extension of time to file it and served a statement of grounds and particulars (SGP) on 17 June 2021. Evidence in Support (EIS) was duly filed on 17 September 2021. The Applicant was advised, by letter dated 22 September 2021, that the EIA was due on 22 December 2021.
On the day the evidence was due, the Applicant requested an extension of time of one month until 22 January 2022 to file EIA. A delegate of the Commissioner requested further information on the extension of time request on 24 December 2021. The delegate sought additional information on 25 January 2022 after receiving a response from the Applicant on 21 January 2022. The Applicant filed a response on 8 February 2022 and also indicated its intention to request a hearing should the delegate remain of the view that the extension of time is not allowable. The delegate was not satisfied with the response and on 15 February 2022 advised the parties that the matter would be referred to a hearing officer to determine, and provided the Opponent one week to request to be heard.
The Opponent did not request to be heard and took no part in this hearing. The Applicant was given until 1 July 2022 to file written submissions.
The law
On 15 April 2013 the Intellectual Property Legislation Amendment (Raising the Bar) Regulation 2013 (No 1) (the Amendment Regulation) commenced. The Amendment Regulation significantly amended the Patents Regulations 1991 (the Regulations) as they apply to patent oppositions. The law governing extensions of time to file evidence in a patent opposition depends upon the date on which the opposition commenced. Where the evidentiary period commenced on or after 15 April 2013, as in the present case, the extension is governed by regulation 5.9 of the Regulations as in force on 15 April 2013.
Subregulation 5.9(2) states:
The Commissioner may extend the period only if the Commissioner is satisfied that:
(a) the party who intended to file evidence in the period:
(i) has made all reasonable efforts to comply with all relevant filing requirements under this Chapter; and
(ii) despite acting promptly and diligently at all times to ensure the appropriate evidence is filed within the period, is unable to do so; or(b) there are exceptional circumstances that warrant the extension.
Exceptional circumstances are defined in subregulation (5):
In this regulation:
exceptional circumstances includes the following:
(a) a circumstance beyond the control of a party that prevents the party from complying with a filing requirement under this Chapter;
(b) an error or omission by the Commissioner that prevents a party from complying with a filing requirement under this Chapter;
(c) an order of a court, or a direction by the Commissioner, that the opposition be stayed pending the completion of a related proceeding or action under the Act.These provisions have been considered by the Deputy Commissioners in TRED Design Pty Ltd v Julie- Anne McCarthy and Bradley McCarthy[1] (the TRED decision) and Merial Limited v Novartis AG[2] (the Merial decision). The principles applied in those decisions, which I accept as correct, are that I must ask myself the following questions:
“1. Has the party (and their attorney or agent) made all reasonable efforts to comply with all relevant filing requirements?
2. Was the failure to file the evidence in time despite the party (and their attorney or agent) acting promptly and diligently at all times to ensure the evidence is filed in time?
3. Were there exceptional circumstances that warrant the extension?
I can extend the time for filing evidence only if I am satisfied that the answer to questions 1 and 2 is YES, or if I am satisfied that the answer to question 3 is YES. If I am so satisfied, then I must consider whether there are any discretionary reasons why the extension should not be granted.”[3]
[1] [2013] APO 57; (2013) 105 IPR 291.
[2] [2013] APO 65; (2013) 105 IPR 133.
[3] TRED decision at [30-31]
The Explanatory Statement accompanying the Amendment Regulation confirms the seriousness of this test:
"A major cause of protracted opposition proceedings is extensions to the various time periods for providing evidence. The law has developed in such a way as to significantly narrow the Commissioner's discretion to disallow extensions. As a result, oppositions are normally subject to multiple extensions of time and extend over many years, contrary to the interest of the public and parties in resolving oppositions faster.
New subregulation 5.9(2) addresses this issue by introducing a new test for determining whether an extension of time for filing evidence is justified. The Commissioner will not be able to extend time periods unless one of these conditions was made out. The party seeking the extension will bear the onus of convincing the Commissioner of this. Once the conditions in subregulation 5.9(2) are met, the Commissioner still has the discretion to consider whether or not it is appropriate that an extension of time be granted. In applying the test, the Commissioner will not be required to give a direction to extend a period solely because of delays caused by a legal representative failing to act promptly or diligently, by difficulties in obtaining expert evidence that could have been anticipated and acted on or by attempts to settle the proceedings.
Where a party cannot satisfy the Commissioner that an extension is justified under the test, the Commissioner will not have the power to give a short extension to allow the filing of evidence immediately available or to validate evidence filed out of time."
If the Commissioner is satisfied that an extension is appropriate, the Commissioner must then determine the length of the extension (subregulation (3)):
The Commissioner must determine the length of the extended period having regard to what is reasonable in the circumstances.
The application for Extension of time
The Applicant has requested an extension of time to file EIA under the provisions of regulation 5.9(2)(a). However, in their submissions, the Applicant has urged the Commissioner to also consider if the requirements of regulation 5.9(2)(b) are fulfilled.[4]
[4] The Applicant’s Submissions, paragraph 11
I will consider the provisions of both regulation 5.9(2)(a) and regulation 5.9(2)(b) for the present circumstances.
In their submissions, the Applicant has summarised the reasons set out by the delegate in their letter of 15 February 2022 for intended refusal as:
i.The Applicant did not act reasonably or diligently when it did not:
·divert Mr. Nigel Harrison to the US Interference Proceedings earlier; or
·“seek out alternative experts for the US and/or Australian proceedings earlier, even if those experts are not the “preferred” choice of the Applicant”;
ii.The Applicant did not act diligently when it overlooked that Mr. Wilson was not able to provide evidence on the common general knowledge as at the earliest priority date; and
iii.The Applicant delayed making amendments to the application.[5]
[5] The Applicant’s Submissions, paragraph 7
I accept that the first two points are a fair summation of the reasons for intended refusal raised by the delegate. However, regarding the third point, the delegate raised lack of information around the circumstances that delayed making amendments as a reason for intended refusal. Regarding the third point, I am satisfied with the explanation provided by the Applicant in its submissions[6] and consider that the Applicant’s conduct regarding the timing of amendments does not lack reasonableness or diligence as far as that impacted the filing of EIA. I will discuss the first two points in detail in my considerations under regulation 5.9(2).
[6] The Applicant’s Submissions, paragraphs 47-50
It is now useful to look at the chronology of events relevant to this extension request. I have used most of the information from the table provided in the declaration made by Karen Sinclair (Annexure A(2)). I have added some information relating to events occurring on specific dates as clarified in the Applicant’s Submissions:
Date Activity undertaken 23 March 2021 Applicant advised of Notice of Opposition and advised to consider early identification of a person or persons who may be engaged to act as an expert 7 May 2021 Notice received from IP Australia that Extension of Time to file Opposition considered allowable 17 May 2021 Applicant opens consideration of possible amendments to the claims also in view of parallel prosecution proceedings in the European Patent Office 17 June 2021 Statement of Grounds and Particulars filed 30 June 2021 Substantive advice re content of Statement of Grounds and Particulars provided to Applicant 22 July 2021 In the parallel European prosecution, a new office action is issued. Further consideration is given to amending the claims on a globally consistent basis. 26 July 2021 Teleconference between Applicant, their German Attorneys, and their Australian attorneys concerning the relevant global legal and commercial circumstances surrounding the opposition 10 August 2021 Mr Nigel Harrison approached to be an expert declarant in the Australian opposition 18 August 2021 Work commences to engage Mr Harrison as expert 25 August 2021, 27 August 2021, 30 August 2021, 31 August 2021, 8 September 2021, 9 September 2021 Discussions continue between Applicant, the Australian Attorneys, the German Attorneys and Mr Harrison re his engagement and ability to assist 31 August 2021 (given as 31 August 2022 in the Applicant’s submissions) * Applicant becomes aware of US interference proceeding, but is not aware of the scope of the proceedings or scope of any expert input required 17 September 2021 Evidence in Support filed 22 September 2021 Period of filing EIA commences 23 September 2021 Evidence in Support forwarded to Applicant and their German Attorneys with prior art overview including initial cross analysis of the prior art references raised in the Statement of Grounds and Particulars, the Evidence in Support and the parallel European prosecution proceedings. 28 September 2021 Mr Harrison formally commences work as expert declarant 30 September 2021, 1 October 2021, 4 October 2021 Communications exchanged regarding opposition strategy and implications of new, related and relevant legal proceedings in the United States of America 6 October 2021 Mr Harrison provided explicit instructions for commencement of evidence preparation in view of Evidence in Support Analysis 7 October 2021 Further written analysis of key issues of Evidence in Support provided by Australian Attorneys to Applicant’s US counsel, German Attorneys and European counsel. 8 October 2021 Teleconference held between Applicant’s US counsel, German Attorneys, European counsel and Australian attorneys re global issues and strategy and implications for Australian opposition 6-22 October 2021** Mr Harrison conducts work on evidence in answer for the present matter 22 October 2021*** The Applicant opened discussion regarding the US interference proceeding with Mr Harrison 4 November 2021 Confirmation received that Mr Harrison no longer available as expert declarant for Australian opposition 19 November 2021 Identity of alternate expert declarant discussed 27 November 2021 Further developments occur in European prosecution relevant to Australian proceeding 1 December 2021 Teleconference re strategy in view of evidence deadline and global developments in related matters and availability of expert declarants, amendments to claims discussed in detail 6 December 2021 Mr Robert Wilson engaged as an alternative expert 8 December 2021 **** Teleconference with Mr Wilson to brief on tasks required to prepare declaration, and all relevant documents provided as basis for commencement of declaration.
It is determined that Mr Wilson is unable to provide evidence on certain matters of CGK and Applicant contacts US attorneys advising them that Mr Harrison is needed back on Australian matter.
10 December 2021 Mr Harrison re engaged to assist with evidence preparation in view of imminent deadline 15 December 2021 Teleconference with Mr Harrison to continue evidence preparation 17-22 December 2021 Mr Harrison continues evidence preparation while on assignment away from home on another project 22 December 2021 Declarations by Mr Harrison and Mr Wilson completed and lodged (as part EIA) * Information obtained from the Applicant’s Submissions, paragraph 28 i
**Information obtained from the Applicant’s Submissions, paragraph 36
*** Information obtained from the Applicant’s Submissions, paragraph 28
**** Information obtained from the Applicant’s Submissions, paragraph 28 viConsideration under regulation 5.9(2)(a)
Paragraph 5.9(2)(a)(i) requires consideration of the reasonableness of the relevant party’s conduct over the totality of the opposition proceedings, rather than its compliance with the particular evidentiary period in question, the latter being addressed by the more specific requirement of paragraph 5.9(2)(a)(ii). [7] Following the filing of Notice of Opposition, SGP and EIS by the Opponent, the filing of EIA was the first requirement in the opposition proceedings with which the Applicant had to comply. Hence, all the relevant actions of the Applicant occurred during the evidentiary period. For this reason, it is not necessary to consider separately whether the Applicant has met the requirements of both regulation 5.9(2)(a)(i) and regulation 5.9(2)(a)(ii). If it has acted promptly and diligently in relation to the preparation and filing of the evidence in answer, it will necessarily have also made all reasonable efforts to comply.
The engagement of Mr Harrison
[7] Merial Limited v Novartis AG [2013] APO 65 at [16].
The Applicant submitted that Mr Harrison was engaged to provide evidence in these proceedings as he was particularly well-placed to provide independent expert evidence.[8] The Applicant also submitted that there was a limited number of other experts that could be called upon to provide equivalent, independent evidence.
[8] The Applicant’s Submissions, paragraph 25
In response to the delegate’s assertion of the Applicant not acting reasonably or diligently by not diverting Mr Harrison to the US interference proceedings earlier, the Applicant submitted:
“Also, a decision to divert Mr Harrison from the Australian proceedings earlier would have made no improvement to the outcomes in the present case. Instead, it would have removed Mr Harrison from conducting the work that occurred between 6 October 2021 and 22 October 2021 on evidence for the present matter. In addition, this would have been holding Mr Harrison in reserve for the US proceedings at a time when it would have been too early in those proceedings for Mr Harrison to contribute. Thus, diverting Mr Harrison from the present proceedings at an earlier stage would have been a less efficient use of Mr Harrison’s time and limited the overall contribution he could make.”[9]
[9] Ibid, paragraph 36
I accept that it was reasonable to not divert Mr Harrison to work on the US proceedings before 22 October 2021 given the Applicant’s submission that no work regarding the US proceedings had started at the time. The Applicant responded to the delegate’s assertion of deprioritising the Australian proceedings by diverting Mr Harrison to the US proceedings, and submitted:
“The Applicant reasonably and diligently, in consultation with Mr Harrison, believed that both tasks were ultimately possible in the time allowed in the respective proceedings. It was then decided, in view of the requirements of the US proceedings, which were due before the end of the Australian evidentiary period (also noting that the US is a vastly more commercially significant market than Australia), that the US proceedings would be given initial priority”.[10]
[10] Ibid, paragraph 31
As per the information from the timeline above, a decision was made within less than 2 weeks (by 4 November 2021) that Mr Harrison could not practicably complete both tasks. A question I thus might ask is what changed within this period of less than a fortnight that the Applicant decided to remove Mr Harrison from the Australian proceedings and seek another expert. The Applicant submitted:
“At the beginning of November 2021, it was becoming apparent that there was a risk that the Evidence in Answer by the deadline of 22 December 2021 would not be met. This was because the volume of Mr Harrison’s commitments in the US matter and the speed of that work, together with the volume of his existing business commitments suggested that he may not complete the necessary work in Australia in time. By 4 November 2021, it was determined that Mr Harrison could not practicably complete all tasks so that steps would have to be taken to engage an alternative expert.
As explained in Annexure C, Mr Harrison commenced work on the US proceedings on 22 October 2021. Accordingly, the revision in the assessment of the volume of work required was made within three (sic) weeks. Thus, it is clear the Applicant was promptly and diligently managing the workflow on the two concurrent matters.”[11]
[11] Ibid, paragraphs 38, 39
Although any circumstance or decision that results in wasted time towards preparing and filing evidence cannot be considered ideal given the strict evidentiary deadlines, it is important to note that regulation 5.9(2)(a) does not require perfection[12], but there needs to be behaviour that is within the range of prompt and diligent.[13]. In this case, the Applicant reassessed the availability of the expert towards Australian proceedings within a fortnight of their work on US proceedings based on the volume and speed of that work, resulting in removing that expert from the Australian proceedings and starting the search for an alternative expert. While the Applicant has not provided specific detail regarding their initial expectations and the subsequent changes, which would clearly have been of great assistance in assessing their action, I consider it reasonable in the circumstances to infer the Applicant, having already some experience with evidence preparation with Mr Harrison, reasonably believed they could meet deadlines in both jurisdictions, and based on subsequent speed and availability of Mr Harrison came to believe this would not be possible.
[12] Mineral Technologies Pty Ltd v Orekinetics Investments Pty Ltd [2014] APO 63 at [33]
[13] Osmose New Zealand v Zelam Limited [2014] APO 49 at [18]
There is no need to discuss whether that decision ultimately proved to be the best one as such a discussion would amount to a retrospective assessment of actions performed rather than assessing whether the actions taken at the time to address any unforeseen circumstance based on the available information were reasonable and within the range of prompt and diligent as required by regulation 5.9(2)(a). In other words, it appears appropriate to consider the nature of the plan for evidence generation as a whole, reassessment of the plan in light of changed circumstances and assess the reasonableness of the revised plan and decide if the actions taken to implement the revised plan is sufficiently prompt and diligent.
I can see the analogy between the present situation and that in UON Pty Ltd v Taranis Power Group Pty Ltd (UON)[14] where an extension was granted after the illness of an expert witness prevented him from completing evidence within the original evidentiary period. The expert in that case had already developed health issues at the time the Notice of Opposition was lodged and was working reduced hours and had advised Mr Keogh that he would still be able to complete his evidence, UON therefore decided to continue with him as expert witness. The delegate stated in his reasons:
“…While in retrospect this may have been a poor decision, I think it is quite reasonable for Mr Keogh to have persisted with Mr Waterreus given his expertise in this technology and Mr Waterreus own belief that he would still be able to provide evidence despite his health issues.”[15]
[14] [2019] APO 6
[15] Ibid at [43]
Similarly, in the present situation, the US proceedings arose unexpectedly and the Applicant in consultation with Mr Harrison believed that work on both Australian and US proceedings would be completed in time. While the circumstances that ultimately prevented the completion of evidence within time appear to be related to Mr Harrison’s commitments and capacity, as opposed to health issues, in both UON and the present situation, there were decisions taken based on changed circumstances which may have led to the delay in filing of evidence. I am satisfied that the decisions by the Applicant regarding Mr Harrison, fall within the realm of promptness and diligence.
The engagement of Mr Wilson
The Applicant submitted:
“Despite the limited time remaining, the Applicant identified a new potential expert (Mr Wilson). Mr Wilson was identified and engaged only about a month after Mr Harrison became unavailable. This timeframe is very reasonable and comparable to timeframes that have been considered reasonable for the engagement of experts in other matters considered by the Commissioner”.[16]
[16] The Applicant’s Submissions, paragraph 41
I accept that the time taken to find another expert is not unreasonably long in this case, particularly when considered with respect to the period of filing evidence itself. However, as per the Applicant’s submission, it was determined shortly after engagement on 8 December 2021, that Mr Wilson was not working in the specific field at the priority date of the Opposed Application. The Applicant submitted:
“As set out in Mr Wilson’s Declaration made on 22 December 2021 for these proceedings, his experience in injection devices dated from 2013 (see [5] of the Wilson Declaration). In addition, Mr Wilson has experience particularly in relation to autoinjector devices dating from 2015 (see [6] of the Wilson Declaration). In this regard, it is noted that the earliest priority date of the Application is also in 2015. As explained in Annexure E, during the opening interview with Mr Wilson on 8 December 2021, it was determined that Mr Wilson’s particular experience in relation to autoinjector devices, rather than injection devices generally, commenced a few months after the earliest priority date”.[17]
[17] Ibid, paragraph 42
The Applicant further submitted:
“A single error in the midst of serious time pressures does not mean that the Applicant has not been prompt and diligent”. [18]
[18] Ibid, paragraph 45
The point to consider is whether the handling of the opposition could still be regarded as reasonable and diligent despite this error of engaging an expert whose particular experience started after the priority date of the Application. It must be remembered that regulation 5.9 does not set a standard of perfection.
To consider the requirements of reasonableness and diligence, a party’s conduct must be considered in the context of the circumstances they are operating in. As per the Applicant’s submissions, there were limited number of other experts that could be called upon to provide equivalent, independent evidence and also that the Applicant was working under serious time pressures. Also, concurrent disputes with overlapping deadlines were going on. I can appreciate that in this case, there might be more than usual pressure on the Applicant because of the decision made about dropping Mr Harrison as an expert mid-way during the evidentiary phase to deal with competing proceedings.
When viewed in this context, the Applicant’s conduct of engaging an alternative expert having experience in the broad technical field of ‘injection devices’, usefully dating before the priority date, in addition to having relevant experience in the particular field of ‘autoinjector devices’, albeit dating a few months after the earliest priority date, does not appear unreasonable. In addition, it is apparent that the time with Mr Wilson was not wasted, as a declaration by Mr Wilson has been filed.
Moreover, it is important to note as per the timeline above, that the error was identified within two days of engaging Mr Wilson (by 8 December 2021) and within the next two days (by 10 December 2021), the preferred expert (Mr Harrison) was re-engaged. This expeditious identification and rectification of the error convinces me that the Applicant’s conduct in relation to the engagement of their experts, although imperfect, was in the range of prompt and diligent.
Overall, I am satisfied that the requirements of regulation 5.9(2)(a) are satisfied; while additional information regarding specific changes and bases for some decisions would have been useful, the Applicant’s conduct in my view falls within the range of what can be considered prompt and diligent.
Consideration under regulation 5.9(2)(b)
The applicant has satisfied both of the first two questions as discussed in paragraph [7]. Consequently, an extension of time is appropriate. The question of whether exceptional circumstances applied in this case is thus moot. Also, the Applicant has not requested the extension on the basis of exceptional circumstances, however, it is still worth a brief consideration. In the TRED decision, the delegate noted that exceptional circumstances are:
“…matters outside the normal evidentiary process, and outside the control of the party, where it would be unreasonable to insist on a party filing their evidence.”[19]
[19] [2013] APO 57; 105 IPR 291
All the circumstances discussed above, for example engaging Mr Harrison, then removing him and re-engaging him as an expert, or engaging Mr Wilson as an expert without realising that his experience in the relevant field starts ‘after’ the priority date of the patent application have contributed towards not filing the evidence in time. Some of these can be categorised as well-meaning decisions while others unintentional errors. However, there is nothing to suggest that the failure to file the evidence within the time was a result of an external event outside the control of the Applicant such as a natural disaster or the sudden illness of a person. In this situation, the provision of regulation 5.9(2)(b) is not enlivened.
Discretionary matters
Once the mandatory requirements of paragraph 5.9(2)(a) have been met, an extension is not automatic; the Commissioner “may” extend the period for filing evidence. I can see no reason not to exercise that discretion.
CONCLUSION
I am satisfied that an extension of time is appropriate. Consequently, I need to consider what length of extension is reasonable in the circumstances. The Applicant has requested an extension of one month. I am satisfied in the circumstances that is an appropriate extension.
Evidence in Answer was filed during the period of the extension, and that evidence in answer is now complete. According to regulation 5.8(4) the time for filing evidence in reply is two months from the day that the Commissioner notifies the opponent that all evidence in answer has been filed. This decision represents such notice.
Pradnya Satarkar
Delegate of the Commissioner of Patents
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